Terms of Service

1. Who you are contracting with

Dossier Flow is provided by The Smart Blend SRL, a private limited liability company incorporated in Belgium, registered office at 2 Avenue Albert Mahiels, 4020 Liege, Belgium, company number 0672.626.308, VAT number BE 0672.626.308 ("we", "us", "our"). Dossier Flow is a product name of that company.

By creating an account you accept these terms on behalf of the organisation you work for ("you", "your"), and you confirm that you are authorised to bind it. Together with the Privacy Notice and the order details shown at the moment of purchase, they form the whole agreement between us.

The service is offered only to organisations acting in a professional capacity. It is not offered to consumers, and it is not available to anyone under 18.

2. What the service does

Dossier Flow prepares draft IUCLID study records, endpoint summaries and hazard assessment values from study reports you upload, for review by your own qualified staff. It also provides a browser extension that writes records you have approved into an IUCLID session that you have opened and authenticated yourself.

IUCLID is published by the European Chemicals Agency. We are not affiliated with, endorsed by, certified by or acting for ECHA. Nothing in the service submits anything to ECHA or to any other authority on your behalf, and no output of the service has any official status.

We are a software vendor. We are not a regulatory consultancy and we do not provide regulatory, toxicological, scientific, legal or other professional advice. Nothing the service produces, including a classification call, a derived no-effect level, an assessment factor or a justification text, is advice, and none of it may be treated as a substitute for the judgment of a qualified person in your organisation.

3. Your responsibility for the content

This clause matters more than any other, so it is stated plainly. Everything the service produces is a draft for expert review. Every derived value is flagged as such. Automated drafting from a study report can misread a table, a unit, a control group or a guideline deviation, and a language model can produce text that reads correctly and is wrong. The design of the service assumes this and is built around review, which is why nothing leaves it unreviewed.

You remain solely responsible for the accuracy, completeness, scientific validity and regulatory adequacy of anything written into your dossier and anything you submit to any authority. Approval inside the service is the act by which one of your users takes that responsibility. Nothing is written to IUCLID without it.

You must not use the service where a failure of it could cause harm to people, and you must not present its output as reviewed when it has not been.

4. Your IUCLID installation

The extension operates inside the authenticated session that you have opened, in the tab you have open, on your own machine. We never receive your IUCLID address, your IUCLID credentials, your IUCLID session or any route into your network, and we hold no ability to act on your installation ourselves.

You confirm that you hold a valid right to use the IUCLID installation you work on, that you have obtained whatever internal authorisation your organisation requires, and that using an automated tool inside it is permitted by the terms of use applicable to that installation. You are responsible for complying with those terms, and for the consequences of records created, modified or deleted in your installation through your approvals.

5. Artificial intelligence, and who provides it

The drafting and reading work is done by large language models supplied to us by Anthropic PBC, under Anthropic's commercial terms. This is a commercial supplier relationship: we pay Anthropic for model capacity, you pay us for the service. We are not an agent, partner, reseller or representative of Anthropic, Anthropic is not a party to this agreement, gives you no warranty and owes you no obligation under it, and we remain fully responsible to you for the service we provide.

Two distinct uses, both stated so there is no surprise:

• Authoring. The text of the study report you uploaded, together with the IUCLID field schema for the endpoint, is sent to the model, which returns structured data that is then validated and put in front of your reviewer.
• Character recognition. Where a report has pages with no usable text layer, typically a scan of an older study, images of those pages are sent to a vision-capable model for transcription, so that the pages can be read at all.

Under Anthropic's commercial terms, content sent through their API is not used to train their models. The model has no access to your IUCLID installation, no credentials and no ability to act on anything: it returns text. What happens to your documents, where they go and how long they are kept is set out in the Privacy Notice.

Models change. We may change model versions or model providers where that keeps the service working or makes it better, and we will keep the Privacy Notice current when we do.

6. Accounts and acceptable use

• You are responsible for your users' credentials and for everything done under them.
• An organisation owner controls who may join the organisation and which browsers are paired.
• You must not upload material you have no right to process, attempt to reach another organisation's data, probe, overload or disrupt the service, reverse engineer it, or resell or sublicense it without a written agreement with us.
• You must not use the service to process special categories of personal data, or any personal data beyond what is incidentally contained in a study report.
• Automated access outside the interfaces we provide, and any use designed to extract our prompts, schemas or model configuration, is not permitted.

Tell us promptly at contact@iucliddossierflow.com if you believe an account or a paired browser has been compromised.

7. Fees, trial and billing

• A free trial of 7 days runs from the creation of your organisation. No payment details are required to begin it. The trial is provided as it stands, and clause 12 applies to it in full.
• Access is then charged at 99 EUR per month per organisation, excluding VAT, billed monthly in advance through our payment processor, Stripe.
• Drafting consumes credits from a wallet you top up in advance. The estimated cost of a drafting job is shown before you start it. Credits are consumed as work is performed, and the amount consumed depends on the size and quality of the documents you process.
• Unused credits do not expire while your account is open, and they are not refundable and not exchangeable for cash. They lapse when the account is closed. We may refund a top-up at our discretion, for example where a job failed on our side.
• VAT is applied according to your country and the VAT number you provide. You are responsible for the accuracy of the billing details and VAT number you give us.
• You may cancel at any time, effective at the end of the paid period. Except where the law requires otherwise, paid fees are not refunded for a period already begun.
• Late payment allows us to suspend access under clause 14, and interest may run at the rate set by Belgian law on late payment in commercial transactions.
• We may change prices on 30 days notice by email, effective at your next renewal. If you do not accept a price change you may cancel before it takes effect.

8. Your data and confidentiality

Your substances, study reports, drafted records and dossier content remain yours. We claim no ownership of them and use them only to provide the service to you. How they are handled, who else is involved and how long they are kept is set out in the Privacy Notice, which forms part of these terms.

We treat your study reports and dossier content as your confidential information. Each of us will keep the other's confidential information confidential, use it only for the purpose of this agreement, disclose it only to staff and processors who need it and are bound to keep it confidential, and protect it with at least reasonable care. This obligation survives the end of the agreement. It does not apply to information that is public through no fault of the receiving party, was already lawfully held, is independently developed, or must be disclosed by law, in which case the disclosing party is told first where that is lawful.

You can export or delete your content and close your account. Records we are legally obliged to retain, such as invoices, are kept for the required period.

9. Intellectual property

We own the service, including the software, the extension, the IUCLID field schemas we maintain, the prompts and everything else we bring to it. You get a non-exclusive, non-transferable right to use it during the subscription, and nothing more is granted by implication.

You keep everything you upload. You grant us only the licence needed to host, process and display it in order to run the service for you, and to allow our processors to do the same. As between you and us, the drafted output generated from your documents is yours, and you may use it without restriction.

Because output is generated from documents you supply, and because similar inputs can produce similar text, we make no claim that output is unique to you, and we remain free to produce comparable output for other customers from their own documents.

If you send us feedback or suggestions, we may use them freely to improve the service, with no obligation and no claim by you.

10. Availability and changes to the service

We aim to keep the service available and to keep improving it. We do not commit to a service level, an uptime figure or a support response time unless one is separately agreed in writing. Maintenance, third party outages, model provider outages and changes to IUCLID itself can all interrupt the service.

We may change or withdraw features. Where a change removes something you rely on, we will give reasonable notice, and where the change is material and to your disadvantage you may cancel without further charge.

11. Warranties

We warrant that we will provide the service with reasonable skill and care, and that we have the right to provide it.

We give no other warranty of any kind. In particular, and given what the service is, we do not warrant that drafted content is accurate, complete, scientifically correct, compliant with REACH or any other regulation, or fit for submission to any authority, nor that the service will be uninterrupted or error free, nor that it will detect every problem in a document you give it. That is exactly why clause 3 places review with you. To the extent permitted by law, all implied warranties and conditions are excluded.

12. Limitation of liability

Nothing in this agreement limits or excludes either party's liability for:

• death or personal injury caused by its negligence;
• fraud or fraudulent misrepresentation;
• its own intentional fault (dol); or
• anything else that cannot lawfully be limited or excluded.

Subject to that, and to the maximum extent permitted by law:

• We are not liable for any indirect or consequential loss, nor for loss of profit, revenue, business, contracts, anticipated savings, goodwill or reputation, business interruption, wasted expenditure, loss or corruption of data, or the cost of procuring substitute services, however arising and whether or not foreseeable.
• We are specifically not liable for regulatory outcomes. This includes a dossier being rejected, incomplete or found non-compliant, a decision, request for information, fine or penalty by ECHA or any other authority, the loss, suspension or delay of a registration, a market access consequence, or any cost of correcting, re-submitting or re-doing work, in each case arising from content you approved. Those outcomes follow from content that a qualified person in your organisation reviewed and approved under clause 3.
• Our total liability for all claims taken together, in contract, in tort including negligence, or on any other basis, arising in any period of 12 consecutive months, is limited to the total amount you actually paid us for the service in the 12 months immediately before the event giving rise to the claim. Where the claim arises during a free trial, or where no fee has been paid, our total liability is limited to 100 EUR.
• Any claim must be notified to us in writing within 12 months of the date on which you became aware, or ought reasonably to have become aware, of the facts giving rise to it. After that it is time barred.

These limits reflect the price of the service, the fact that all output is drafted for your review, and the fact that we have no visibility of, and no control over, what is finally written into your dossier or submitted to an authority. You accept that this allocation of risk is reasonable, and that the price would be different without it.

13. Your indemnity

You will indemnify us against any third party claim, and any fine or order imposed on us, arising from material you uploaded that you had no right to process, from your use of the service in breach of clause 6, from your use of your IUCLID installation, or from content you approved and submitted to an authority.

14. Suspension and termination

You may stop using the service at any time. We may suspend or terminate an account for non-payment, for a serious or repeated breach of clause 6, where required by law, or where continued operation would pose a security risk, with notice where the circumstances allow it and immediately where they do not. We will restore access once the cause is resolved.

We may also terminate the agreement for convenience on 30 days notice, in which case we refund the unused part of any subscription period you have already paid for.

On termination, access ends and content is deleted according to the retention rules in the Privacy Notice. Export what you need before you close the account. Clauses 3, 8, 9, 12, 13 and 15 survive termination.

15. Governing law and disputes

This agreement is governed by Belgian law, without regard to its conflict of law rules and excluding the UN Convention on Contracts for the International Sale of Goods. The courts of Liege, Belgium have exclusive jurisdiction, without prejudice to any mandatory protection available to you under the law of your own country.

Before starting proceedings, each of us will try in good faith to resolve the matter by writing to the other and allowing 30 days for a reply.

16. General

• Force majeure. Neither party is liable for a failure caused by something outside its reasonable control, including outages at a hosting, model or payment provider, network failure, or an act of a public authority.
• Subcontracting. We may use the processors listed in the Privacy Notice, and we remain responsible for their performance.
• Assignment. You may not assign the agreement without our written consent. We may assign it to a group company or to an acquirer of the business, on notice to you.
• Severability. If a provision is held unenforceable, it is limited to the minimum extent necessary and the rest stands.
• No waiver. Not enforcing a right does not waive it.
• Notices. We write to the email address on your account. You write to the contact address below. Notices take effect on the day after sending.
• Entire agreement. These terms, the Privacy Notice and the order details replace anything said or written before. Neither party relies on any statement not set out in them, except in the case of fraud.
• Language. The English version of these terms prevails over any translation.

17. Changes to these terms

We may update these terms. Material changes will be notified to account holders by email at least 30 days before they take effect. Continuing to use the service after that date means you accept the revised terms. If you do not, you may cancel before they take effect and we will refund the unused part of the current period.

18. Contact

Questions about these terms: contact@iucliddossierflow.com. Postal address: The Smart Blend SRL, 2 Avenue Albert Mahiels, 4020 Liege, Belgium.